At the Mercy of the Artificial Intelligence Algorithm: Discrepant Polymerase Chain Reaction Results.

Abstract

As pathogen molecular diagnostics technology develops, the software analysis of polymerase chain reaction sigmoidal curves, cycle threshold (Ct) values, and the limit of nucleic acid detection for that assay is not always available when reporting test results. These are critical components in interpreting results and can affect the management of patients. Our view is that all commercial assay providers must ensure that users, as they can with laboratory-developed tests, are able to see the curve and Ct value for all samples. Some examples demonstrating this principle are included. Regulatory bodies have a key role to play.